Sage Group Represents Squarex's SQX770: A Novel Immunologic Approach for the Prevention of Cold

The Sage Group is pleased to announce it has been appointed to represent a product from Squarex LLC, SQX770, the only product which prevents cold sores (herpes labialis), meaning it significantly reduces the number of cold sore flareups in a given period and reduces the severity when there are flareups. Please see the attached nonconfidential presentation.

Squarex, LLC, has pioneered the use of squaric acid dibutyl ester (SADBE) to prevent cold sores (herpes labialis) resulting from herpes simplex infection. Squarex’s formulation of SADBE, designated SQX770, is a 2% solution in a base formulation of DMSO applied to the upper arm or elsewhere in the periphery. The mechanism of action is a systemic immunologic reaction caused by the stimulation of dendritic cells which are plentiful in the dermal layer. Squarex’s published preclinical data supports this immunologic mechanism of action.

Squarex has completed a Phase 1 study and two Phase 2 studies, all three of which showed significant efficacy. Two of the studies had the endpoint of outbreaks, with both reaching statistical significance with respect to the reduction in the number of “events” and severity compared to placebo. The third study looked at the mechanism of action and cellular immune response and showed statistically significant increase in immune response to the HSV-1 virus after dosing in persons with frequent cold sores. Squarex is preparing to request an end of Phase 2 meeting with the FDA and to present an outline of the protocols for two simultaneous Phase 3 studies.

Squarex seeks a global or regional partner (or acquirer) to conduct the Phase 3 studies, gain regulatory approval, and commercialize SQX770.

As background, there are two types of treatments for "cold sores/fever blisters", e.g., herpes labialis, a term used to describe an infection characterized by an eruption of small and usually painful blisters on the lips, mouth, or the skin around the mouth. One is traditional medicine and the other is natural cures. There are no vaccines for herpes labialis nor are there any products for its prevention.

According to information published by the World Health Organization (WHO) nearly 67% of the world’s population are infected by the HSV-1 strain of herpes simplex, approximately 4.7 billion people worldwide living with this condition. The CDC suggests that one in every six individuals around the world has genital herpes (a variation of the herpes simplex virus), and that the overwhelming majority of them are unaware of the fact that they are living with this medical condition all along.

Traditional treatments include docosanol, e.g., Abreva from GSK Consumer, which is a saturated fatty alcohol that blocks the virus which causes the herpes simplex virus from entering the healthy skin cells and replicating in number. It is deemed safe and its topical application is approved by the FDA. It can speed the healing of the sores and decrease symptoms (such as tingling, pain, burning, itching),but it does not prevent future outbreaks. There are other treatments such as antiviral creams (e.g. ProsurX, a topical OTC medicine containing both anti-viral nanoparticles and natural anti-viral essential oils) zinc oxide, zinc sulfate and anesthetics. There are also antiviral drugs (acyclovir, penciclovir, famciclovir, valacyclovir, etc.) that facilitate healing to some extent. These are expensive and come with many side effects.

In contrast, SQX 770 is for preventing outbreaks. Prevention is better than reducing symptoms after an outbreak occurs. And again there is nothing that has been approved for preventing herpes labialis outbreaks. SQX770 has also been shown to be very safe.

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Fax: +1 908 2319692 wp@sagehealthcare.com